Career and Professional Development

Clinical and Translational Nutrition

Laboratory Management and Statistical Analysis Plans for Clinical Nutrition Studies

Speaker(s)

• KB

  Kathryn Barger, PhD

  Senior Statistician
  JM USDA HNRCA at Tufts University
  Boston, Massachusetts, United States

  Disclosure(s): No relevant financial relationship(s) with ineligible companies to disclose.
• 

  Penny Kris-Etherton, Ph.D.

  Professor
  Nutritional Sciences
  The Pennsylvania State University
  University Park, Pennsylvania, United States

  Disclosure(s): American Pecan Council: Grant/Research Support (Ongoing)
  American Pistachio Growers: Grant/Research Support (Ongoing)
  Hass Avocado Board: Grant/Research Support (Ongoing)
  Heali: Advisory Committee/Board Member (Ongoing)
  HumanN: Advisory Committee/Board Member (Ongoing)
  McCormick Spice Institute: Grant/Research Support (Ongoing)
  Seafood Nutrition Partnership: Advisory Committee/Board Member (Ongoing)
• 

  Kevin Maki, PhD

  President and Chief Scientist
  Midwest Biomedical Research
  Addison, Illinois, United States

  Disclosure(s): Acasti Pharma Inc.: Consultant (Ongoing)
  Beren Therapeutics: Consultant (Ongoing)
  Eli Lilly and Co.: Consultant (Ongoing)
  Naturmega: Grant/Research Support (Ongoing)
  New Amsterdam Pharma: Consultant (Ongoing)
  NorthSea Therapeutics: Consultant (Ongoing)
  Novo Nordisk Pharma Inc.: Consultant (Ongoing)
  Pharmavite: Grant/Research Support (Ongoing)
• GM

  George McCabe, PhD

  Emeritus Professor, Department of Statistics
  Purdue University
  West Lafayette, Indiana, United States

  Disclosure(s): No relevant financial relationship(s) with ineligible companies to disclose.
• 

  Joshua Miller, PhD (he/him/his)

  Professor & Chair of Nutritional Sciences
  Department of Nutritional Sciences, Rutgers University
  New Brunswick, New Jersey, United States

  Disclosure(s): Church & Dwight Co.: Consultant (Terminated); Independent Contractor (including contracted research) (Terminated)
• 

  Kristina Petersen, PhD, APD, FAHA

  Assistant Professor
  Nutritional Sciences
  Texas Tech University & Pennsylvania State University
  Lubbock, Texas, United States

  Disclosure(s): McCormick Science Institute: Advisory Committee/Board Member (Ongoing); Grant/Research Support (Ongoing)
• 

  Connie Weaver, PhD (she/her/hers)

  Distinguished Professor of Research
  San Diego State University
  San Diego, California, United States

  Disclosure(s): No relevant financial relationship(s) with ineligible companies to disclose.

Overview
Human nutrition randomized controlled trials (RCTs) have unique considerations and conducting them with the highest scientific rigor is essential to the development of evidence-based dietary guidance for promoting optimal health and advancing health care. Diet-related interventions can include diet and/or behavioral manipulation, provision of foods or entire meals, or delivery of dietary components in individual food items or supplements.

Join an esteemed faculty for a training on the design and conduct of human nutrition RCTs, documentation and reporting of all aspects of clinical trial management, and data analysis and reporting of results. Course content is based on a series of articles published in Advances in Nutrition; see reading assignments below.

Target Audience

• Faculty in graduate nutrition/obesity and related programs
  
• NIH-funded Nutrition Obesity Research Center members
  
• Graduate students and early career professionals
  
• Contract research organizations staff
  
• International nutrition societies members
  
• Industry scientists
  
• Funding agencies personnel
  
• Clinical research oversight committee members and auditors

Course Format
The course will be conducted virtually and consists of plenary sessions with lectures and panel discussions. Programming will end each day with an interactive breakout session where practical aspects can be reviewed and discussed in smaller group forums.

A certificate of attendance will be provided at the conclusion of the training. Presentations and course resources will be archived for on-demand viewing.

Reading Assignments as Preparation for Course Attendance

Presentations:

• 12:00 PM – 12:10 PM ET

  Welcome and Introductions (Laboratory Management and Statistical Analysis Plans for Clinical Nutrition Studies)
  

  Speaker: Penny M. Kris-Etherton, Ph.D. – The Pennsylvania State University
• 12:10 PM – 12:20 PM ET

  Session 1: Laboratory Management and Statistical Analysis Plans for Clinical Nutrition Studies Part 1 / Elements and Purpose of a Statistical Analysis Plan (Laboratory Management and Statistical Analysis Plans for Clinical Nutrition Studies)
  

  Speaker: Kristina S. Petersen, PhD, APD, FAHA – Texas Tech University & Pennsylvania State University
• 12:20 PM – 12:50 PM ET

  Preparing a Statistical Analysis Plan (Laboratory Management and Statistical Analysis Plans for Clinical Nutrition Studies)
  

  Speaker: George P. McCabe, PhD – Purdue University
• 12:50 PM – 1:20 PM ET

  Session 1 Panel Discussion (Laboratory Management and Statistical Analysis Plans for Clinical Nutrition Studies)
  

  Speaker: Kathryn Barger, PhD – JM USDA HNRCA at Tufts University

  Speaker: George P. McCabe, PhD – Purdue University

  Speaker: Joshua W. Miller, PhD (he/him/his) – Department of Nutritional Sciences, Rutgers University

  Speaker: Connie M. Weaver, PhD (she/her/hers) – San Diego State University
• 1:50 PM – 2:15 PM ET

  Laboratory Considerations (Laboratory Management and Statistical Analysis Plans for Clinical Nutrition Studies)
  

  Speaker: Joshua W. Miller, PhD (he/him/his) – Department of Nutritional Sciences, Rutgers University
• 2:15 PM – 2:45 PM ET

  Completing Statistical Analyses and Reporting Results (Laboratory Management and Statistical Analysis Plans for Clinical Nutrition Studies)
  

  Speaker: Kathryn Barger, PhD – JM USDA HNRCA at Tufts University
• 2:45 PM – 3:20 PM ET

  Data Management Planning and Execution (Laboratory Management and Statistical Analysis Plans for Clinical Nutrition Studies)
  

  Speaker: Kevin C. Maki, PhD – Midwest Biomedical Research
• 3:20 PM – 3:50 PM ET

  Session 2 Panel Discussion (Laboratory Management and Statistical Analysis Plans for Clinical Nutrition Studies)
  

  Speaker: Kathryn Barger, PhD – JM USDA HNRCA at Tufts University

  Speaker: Kevin C. Maki, PhD – Midwest Biomedical Research

  Speaker: George P. McCabe, PhD – Purdue University

  Speaker: Joshua W. Miller, PhD (he/him/his) – Department of Nutritional Sciences, Rutgers University

  Speaker: Connie M. Weaver, PhD (she/her/hers) – San Diego State University
• 3:50 PM – 3:55 PM ET

  Highlights (Laboratory Management and Statistical Analysis Plans for Clinical Nutrition Studies)
  

  Speaker: Kevin C. Maki, PhD – Midwest Biomedical Research